Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Obsessive-Compulsive Disorder

In brief

The study's purpose is to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)

Key facts

Study ID

NCT04641143

Run by

Biohaven Pharmaceuticals, Inc.

People needed

456

Starts

2020-12-22

Expected to finish

2025-10-27

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at Screening; The duration of the subject's illness must be ≥ 1 year
• An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response as defined per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the subject
• Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trial as designed

You may not qualify if…

• Subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the MGH-TRQ-OCD.
• Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourette's disorder, body dysmorphic disorder, hoarding disorder; or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results
• Previous treatment in a study with troriluzole

Where it is running

• IMA Clinical Research — Phoenix, Arizona, United States
• NoeisisPharma, LLC — Phoenix, Arizona, United States
• CITrials (Clinical Innovations) — Bellflower, California, United States
• Axiom Research, LLC — Colton, California, United States
• WR-PRI, LLC (Encino) — Encino, California, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Clarity Clinical Research — Los Angeles, California, United States
• Excell Research, Inc — Oceanside, California, United States
• NRC Research Institute — Orange, California, United States
• Anderson Clinical Research — Redlands, California, United States
• Lumos Clinical Research Center, LLC — San Jose, California, United States
• California Neuroscience Research Medical Group, Inc — Sherman Oaks, California, United States
• Stanford University — Stanford, California, United States
• Collaborative Neuroscience Research — Torrance, California, United States
• Yale University / Connecticut Mental Health Center — New Haven, Connecticut, United States
• Comprehensive Psychiatric Care — Norwich, Connecticut, United States
• Boca Raton Medical Institute — Boca Raton, Florida, United States
• Advanced Clinical Research Network — Coral Gables, Florida, United States
• Research in Miami Inc — Hialeah, Florida, United States
• Accel Research Sites — Lakeland, Florida, United States
• Innovative Clinical Research, Inc. — Lauderhill, Florida, United States
• Health Care Family Rehab & Research — Miami, Florida, United States
• Central Miami Medical Institute — Miami, Florida, United States
• Metropolitan Neuro Behavioral Institute — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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